Single-cell immune profiling to distinguish responders and non-responders to immunotherapy in advanced liver cancer
Official title: Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07273708 · Data updated 2026-11-12
This research will see if single-cell RNA patterns in blood immune cells can predict which patients with advanced liver cancer respond to immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, tremelimumab, durvalumab, immunotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | March 15, 2025 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT07273708 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with advanced hepatocellular carcinoma starting first-line immunotherapy (atezolizumab plus bevacizumab or tremelimumab plus durvalumab) who can give informed consent.
✕Probably not a fit
Patients with life expectancy under 12 months due to other diseases, active autoimmune or immune deficiency conditions, ongoing drug abuse, or recent other malignancies meeting exclusion criteria are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects peripheral blood mononuclear cells (PBMCs) from adults with advanced hepatocellular carcinoma receiving first-line immune checkpoint regimens (atezolizumab plus bevacizumab or tremelimumab plus durvalumab). Investigators will perform single-cell transcriptomics on PBMCs before and after treatment to identify changes linked to clinical response. They will also test whether pre-treatment PBMC signatures predict which patients have durable responses. As an exploratory step, patient PBMCs previously exposed to checkpoint inhibitors will be co-cultured with matched tumor organoids to see if those laboratory models reflect actual clinical outcomes.
Why it matters
Potential benefit: If successful, the study could help doctors predict who will benefit from immunotherapy and guide more personalized treatment decisions.
How similar studies have gone: Similar single-cell immune profiling approaches in other cancers have shown promising predictive signals, but prospectively validated blood-based signatures for HCC are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. diagnosis of advanced HCC treated with atezolizumab plus bevacizumab or tremelimumab single dose plus durvalumab (STRIDE regimen) as first-line treament 2. age ≥18 and \<90 years at time of signing informed consent 3. Signed Informed Consent Form Exclusion Criteria: 1. Life expectancy of \<12 months due to concomitant diseases 2. Active or history of autoimmune disease or immune deficiency on inflammatory chronic diseases 3. Ongoing drug abuse 4. History of malignancy other than HCC within 3 years prior to study entry with the following exception: 1. Completely resected malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%) and without evidence of recurrence for \> 3 years prior to study entry 2. adequately treated non-melanoma skin carcinoma or lentigo maligna without evidence of metastases. 3. adequately treated carcinoma in situ of the cervix without evidence of recurrence 4. localised prostate cancer 5. adequately treated non invasive or in situ urothelial cancers 5. evidence or history of positive HIV test 6. inability to comply with the study protocol, in the investigator's judgment
Where it's running
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Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Salvatore Corallo
- Email: s.corallo@smatteo.pv.it
- Phone: +39 0382501557
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.